Signals, Powered By EquityPandit
According to the latest U.S. Food and Drug Administration’s (USFDA) Enforcement Report, Indian pharma major such as Lupin, Sun Pharma and Glenmark has decided to recall some of its products from the United States market.
Lupin Pharmaceuticals, as per the report, voluntarily recalled 55,000 vials and over 1.6 lakh boxes of antibacterial drug Ceftriaxone for injection in various strengths. It is said that the products are being recalled due to the presence of particulate matter.
USFDA said, “Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.” Besides, Lupin is also recalling 2.8 lakh bottles of Cefdinir for Oral Suspension which is used to treat bacterial infections.
The US FDA has classified the product recall as a Class-II recall, which is issued in a situation where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Besides Lupin, Sun Pharma has also voluntarily recalled 13,918 cartons and over 1.39 lakh vials of Vecuronium Bromide for Injection which is used as part of general anaesthesia, due to the presence of particulate matter. Glenmark Pharmaceuticals is recalling 96,240 applicators of its product Estradiol Vaginal Inserts for the defective delivery system.
